Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5.025 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
5
Dose descriptor:
NOAEC
Value:
50 mg/m³
AF for dose response relationship:
1
Justification:
The NOAEC is used as starting point.
AF for differences in duration of exposure:
1
Justification:
The sub-chronic study of Buschmann et al. (2003) is used as starting point. Results of that study show that effects were comparable or even less severe after 91 days when compared with effects after 3 or 28 days of treatment. Therefore, a factor of 1 is used due to the specific evidence that increasing exposure duration does not increase the incidence or severity of adverse effects.
AF for interspecies differences (allometric scaling):
1
Justification:
No allometric scaling is necessary.
AF for other interspecies differences:
1
Justification:
Observed effects in the study of Buschmann et al. (2003) are based on direct chemical/pH reactivity of the test substance. Additionally, irritating effects were only observed in the upper part of the respiratory tract. Therefore, differences in deposition, airflow patterns, clearance rates and protective mechanisms were not considered and the default factor can be reduced to 1.
AF for intraspecies differences:
5
Justification:
Default factor for workers is used.
AF for the quality of the whole database:
1
Justification:
The key study is a GLP compliant guideline study, therefore no further assessment factors are required.
AF for remaining uncertainties:
1
Justification:
The key study is a GLP compliant guideline study, therefore no further assessment factors are required.
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

The German Federal Institute for Occupational Safety and Health (BAuA/TRGS 900) discussed a scientific OEL for dibutylamine (CAS 111-92-2) of 29 mg/m3 (= 5 ppm). This was done analogously to the OELs of the two short-chain alkylamines diisopropylamine (CAS 108-18-9) and monobutylamine (CAS 109-73-9), based on similar LD/LC50 values and RD50 values in mice. However, the 90 -day repeated dose inhalation study was not yet available / included in the assessment. Based on these data for local effects after repeated sub-chronic exposure, a lower DNEL is justified.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

Since there are no consumer uses of dibutylamine (CAS 111-92-2) and, therefore, relevant exposure of the general population can be ruled out, DNEL derivation for the general population is not required.